NCT00653796

Ezetimibe Plus Atorvastatin Versus Atorvastatin in Untreated Subjects With High Cholesterol (P03434)

SCH 58235: A Multicentre, Randomised, Parallel Group, Placebo-Controlled Study Comparing the Efficacy, Safety, And Tolerability of the Daily Co-Administration of Ezetimibe 10 mg With Atorvastatin 10 mg vs. Ezetimibe Placebo With Atorvastatin 10 mg in Untreated Subjects With Primary Hypercholesterolaemia and Coronary Heart Disease

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 148 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study was designed to assess whether co-administration of ezetimibe 10 mg with atorvastatin 10 mg in treatment naïve subjects would be more effective than treatment with atorvastatin 10 mg alone for reducing LDL-concentrations.

Conditions

• Hypercholesterolemia
• Atherosclerosis

Interventions

Type	Name	Description
DRUG	Ezetimibe + Atorvastatin	oral tablets: ezetimibe 10 mg + atorvastatin 10 mg once daily for 6 weeks
DRUG	Atorvastatin	oral tablets: atorvastatin 10 mg + ezetimibe placebo once daily for 6 weeks

Timeline

• Start date: 2003-09-01
• Primary completion: 2004-08-01
• Completion: 2004-08-01
• First posted: 2008-04-07
• Last updated: 2024-08-15